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Study of Investigational Agents for Esophageal Cancer

This study is for people with advanced esophageal squamous cell carcinoma (a type of cancer in the esophagus, the tube that connects your throat to your stomach) that has progressed after prior treatment, including a PD-1/PD-L1 blocking drug like pembrolizumab. Researchers are testing different combinations of investigational agents (drugs being studied) with or without pembrolizumab, paclitaxel, or irinotecan. The goal is to understand the safety of these treatments, specifically looking at side effects and how many people stop treatment due to side effects during the first three weeks. You must be at least 18 years old and have a confirmed diagnosis of this type of esophageal cancer that has worsened after previous treatment. The study is no longer enrolling for combinations of pembrolizumab with MK-4830 and either paclitaxel/irinotecan or lenvatinib.

Study design
This is a Phase 1/2, multi-center, open-label study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll about 230 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety is measured for up to approximately 3 weeks during an initial phase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05319730

A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~230 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:PaclitaxelIrinotecanPembrolizumabMK-4830LenvatinibSacituzumab tirumotecan

At a glance

Recruiting sites
49 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) During Safety Lead-in Phase
Measured over Up to approximately 3 weeks
+3 more outcomes measured

Conditions

Esophageal Squamous Cell Carcinoma

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NCT05319730

Where you'd take part

This study runs at 58 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417)

    Adana, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Aichi Cancer Center ( Site 3702)

    Nagoya, Aichi-ken, Japanstudy coordinator listed

    Recruiting

  • Anhui Provincial Hospital ( Site 3501)

    Hefei, Anhui, Chinastudy coordinator listed

    Recruiting

  • Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Asan Medical Center-Department of Oncology ( Site 3901)

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Atatürk Üniversitesi-onkoloji ( Site 3416)

    Erzurum, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana ( Site 3206)

    Pisa, Tuscany, Italystudy coordinator listed

    Recruiting

  • Beijing Cancer hospital-Digestive Oncology ( Site 3500)

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy
Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice
Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible

Exclusion

Direct invasion into adjacent organs such as the aorta or trachea
Has experienced weight loss \>10% over approximately 2 months prior to first dose of study therapy
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
History of allogenic tissue/solid organ transplant
Clinically significant cardiovascular disease within 12 months from first dose of study intervention
Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization

What this trial measures

  • Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) During Safety Lead-in PhaseUp to approximately 3 weeks

    A DLT is defined as any drug-related AE according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.

  • Number of Participants Who Experienced an Adverse Event (AE) During Safety Lead-in PhaseUp to approximately 3 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  • Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in PhaseUp to approximately 3 weeks

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

  • Objective Response Rate (ORR)Up to approximately 48 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.